OnCo
trialsTrialNegative

ASTRA

Adding a MEK inhibitor to boost iodine uptake before ablation did not improve complete remission rates, cooling the 'redifferentiation for everyone' idea.

Complete remission at 18 months 40% vs 38.5%; no benefit. Redifferentiation remains reserved for selected radioiodine-refractory patients, where MEK or BRAF/MEK inhibitors can restore uptake in about half.

Setting
High-risk differentiated thyroid cancer: selumetinib + adjuvant radioiodine vs placebo + radioiodine
Phase
Phase 3
Sponsor
AstraZeneca
Registry
Headline result
Complete remission 40% vs 38.5%; not significant.
Reported
2019
Enrolled
401
Replication
Small redifferentiation series remain positive in refractory patients; the adjuvant setting was negative.

Outcomes

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In plain words
What these results mean for people, not percentages
401 people took part
Complete remission at 18 monthsprimarysurrogate endpoint
  • 40 vs 38.5 out of 100 had no sign of cancer on scans or tests with Selumetinib + RAI compared with Placebo + RAI; 1.5 more per 100.
  • Roughly one extra person helped for every 67 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
  • This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
  • These results apply to the people the trial enrolled: High-risk differentiated thyroid cancer: selumetinib + adjuvant radioiodine vs placebo + radioiodine. People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

401 participants enrolled.

Complete remission at 18 monthsprimary
Selumetinib + RAI40 of 100
Placebo + RAI38.5 of 100
Source
EndpointArmnValueHR (95% CI)pSource
Complete remission at 18 monthsprimarySelumetinib + RAI40%link
Placebo + RAI38.5%
Replication
Small redifferentiation series remain positive in refractory patients; the adjuvant setting was negative.

Connected

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